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Recruiting NCT06492876

Gene Therapy for DME

Phase I / Phase II Interventional Diabetic Macular Edema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FT-003.
Who it may be relevant to
Registry conditions: Diabetic Macular Edema. Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME

Overview

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Interventions

  • Genetic FT-003
    Administered via intraocular injection.

Primary outcome measures

  • Safety and tolerability after FT-003 injection [Time frame: At Week 12]
Secondary outcome measures (1)
  • To evaluate the efficacy after FT-003 injection [Time frame: At Week 24]

Eligibility criteria

Inclusion criteria

  • Subjects that are willing and able to follow study procedures;
  • Female or male patients 18-74 years old at the time of signing the ICF;
  • Clinically diagnosed with CI-DME;
  • The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;

Exclusion criteria

  • Presence of any other intraocular diseases other than DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Eye Hospital — Tianjin

Identifiers

NCT: NCT06492876 · FT003-CD101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗